NCT01875783: DME FOUND

OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Completed NA Results posted Last updated 22 December 2017

What this trial tests

NA trial testing OCT imaging in Diabetes in 385 participants. Completed in 15 July 2016.

Timeline

17 March 2014

Primary endpoint
14 May 2015

15 July 2016

Quick facts

Lead sponsor	Joslin Diabetes Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	double
Primary purpose	diagnostic
Enrollment	385
Start date	17 March 2014
Primary completion	14 May 2015
Estimated completion	15 July 2016
Sites	4 locations across United States

Drugs / interventions tested

• OCT imaging

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

Joslin Diabetes Center — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rates of Retina Care Referral for Patients With Diabetic Macular Edema Primary · Baseline visit

Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

Group	Value	95% CI
Retina Specialist Care	44

Retinal Referral Rates for Patients With DME Secondary · Baseline visit

Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

Group	Value	95% CI
Eyes That Have Undergone OCT Imaging	59

Rates of Retinal Treatment for Patients With DME Secondary · One month

Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment

Group	Value	95% CI
Participants Referred for Retina Care	14

Rates of Retinal Treatment Over 1 Year for Patients With DME Secondary · 9 months

Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist

Group	Value	95% CI
Participants Referred for Retina Care	18

Sponsor's own description

The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Retinal Telemedicine.
   Chee RI, Darwish D, Fernandez-Vega A, Patel S, et al · · 2018 · cited 18× · PMID 30140593 · DOI 10.1007/s40135-018-0161-8